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New treatment option for Endoscopic Ultrasound-Guided Radiofrequency Ablation
Official title Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors
ClinicalTrials.gov ID: NCT07536087
What this study is testing
- What it's testing
- The primary aim of this study is to evaluate the technical feasibility and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) in the treatment of pancreatic cystic neoplasms (PCNs) and pancreatic neuroendocrine tumors (pNETs) in patients who are not suitable candidates for surgical treatment or who refuse surgery. EUS-RFA, as a minimally invasive therapeutic option, may potentially reduce the need for intensive imaging surveillance, prevent further progression of these lesions, and serve as a bridging therapy in selected patients for whom surgical intervention may be considered in the future.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team
- Capability of giving informed consent PCN Inoperability or refusal of surgery
- Branch duct IPMN (BD-IPMN) with worrisome features:
- Jaundice
- High grade dysplasia or cancer
You likely can't join if
- Known bleeding disorder that cannot be sufficiently corrected with medication
- Use of anticoagulants that cannot be discontinued
- Physical and/or psychological inability to understand the aims of the research and to adequately cooperate
- Pregnancy
- Inability to sign the informed consent
See the full eligibility criteria
- Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team
- Capability of giving informed consent PCN Inoperability or refusal of surgery
- Branch duct IPMN (BD-IPMN) with worrisome features:
- Jaundice
- High grade dysplasia or cancer
- Solid mass/nodule \> 5mm
- Main pancreatic duct dilation \> 10mm Or at least one (patients without comorbidities) or at least two (patient with comorbidities) of the following risk features:
- CA 19-9\> 37 U/ml
- Increase in size \> 5mm/year
- Dilation of the main pancreatic duct between 5-10mm
- Size ≥ 40mm
- Symptoms (new onset of diabetes, acute pancreatitis)
- Nodule \< 5mm Pancreatic NET
- Size \< 2 cm
- Histological proof in non-functional lesions/histological proof or clinical proof in functional lesions
- 68Ga-DOTATATE PET/CT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases
- G1 or G2 (\<5 %) histology
- Known bleeding disorder that cannot be sufficiently corrected with medication
- Use of anticoagulants that cannot be discontinued
- Physical and/or psychological inability to understand the aims of the research and to adequately cooperate
- Pregnancy
- Inability to sign the informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.